To Evaluate the Safety, Activity and Pharmacokinetics of Marqibo in Children and Adolescents With Refractory Cancer
Status:
Completed
Trial end date:
2014-12-01
Target enrollment:
Participant gender:
Summary
Background:
- Marqibo(Registered Trademark) is a new anticancer drug. It combines Vincristine sulfate,
which is a widely used anticancer drug, and packages it into a tiny fat bubble known as
a liposome. The goal of this is to improve the drug's ability to destroy cancer cells
and help reduce the potential side effects of treatment.
- Vincristine sulfate was originally developed from chemicals found in the periwinkle
plant and acts against multiple types of malignant cancer. It is approved for multiple
cancer types including solid tumors and blood cancers.
- Research has shown that Marqibo(Registered Trademark) is able to slow or stop the growth
of cancer cells in some adults, both alone and in combination with other chemotherapy
drugs, but more research is needed to determine its use in children.
- There has been one previous small study of Marqibo(Registered Trademark) in children.
Although some anti-cancer activity was seen, side effects and optimal dosing were not
fully determined.
- As is seen with standard Vincristine suflate, the most common side effect of
Marqibo(Registered Trademark) involves the nervous system. It can cause numbness and
tingling in the hands and feet. Symptoms commonly improve when the drug is discontinued
or the dose is lowered.
Objectives:
- To determine the safety and efficacy of Marqibo as a treatment for children who have been
diagnosed with certain types of malignant cancer that has not responded to standard
treatment.
Eligibility:
- Children and adolescents between 2 and 21 years of age who have been diagnosed with
certain types of malignant cancer that has not responded to standard treatment.
- These cancer types include solids tumors, primary brain tumors, leukemias, and
lymphomas.